by Marion Nestle

Currently browsing posts about: Supplements

Feb 21 2019

The FDA is taking on the supplement industry?

I thought the FDA had decided long ago that dietary supplements were untouchable, given the Courts’ interpretation of the Dietary Supplement Health and Education Act (DSHEA) of 1994.  DSHEA essentially deregulated dietary supplements and blocked the FDA from doing much about them unless it could prove substantial harm.

Whenever the FDA tried to intervene, supplement companies took the agency to court on First Amendment grounds, and won most of the time.  So the FDA appeared to have given up.

But here we have FDA Commissioner Scott Gottlieb announcing new steps to take back some oversight of this industry.

These steps include communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.

The FDA issued a press release to announce 12 warning letters and 5 online advisory letters to companies illegally selling more than 58 misbranded products claimed to prevent or treat Alzheimer’s disease.  The demographic change to an aging population:

has been accompanied by a growth in the number of marketers who prey on this population, pitching products that make unproven claims that they can prevent, treat, delay, or even cure Alzheimer’s disease.  These purported miracle cures are sold primarily on the Internet. They are often, though not always, falsely labeled as dietary supplements. Regardless of their form, these products fly in the face of true science. What these companies are selling is the false hope that there is an effective treatment or cure.

Commissioner Gottlieb also sent out a chain of Twitter announcements explaining what this is about.

Cheers to the FDA for this one.  And now get busy on the rest of the bad apples in this barrel.

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Jan 9 2019

Supplements to improve memory: if only

The Government Accountability Office has just published a report on memory supplements.

Available data indicate that memory supplements constitute a small segment of the overall dietary supplement market, but their sales nearly doubled in value from 2006 to 2015, increasing from $353 million to $643 million. Consumers searching to prevent or treat age-related memory loss, including Alzheimer’s disease, have increasingly turned to dietary supplements for help.

What did the GAO do?

This report examines the extent to which selected memory supplements contained: (1) their stated ingredients at the quantities stated on their labels and specific adulterants, and (2) certain contaminants.

Uh oh.  Never mind whether memory supplements do any good (a dubious claim).  They don’t even contain what they claim to contain:

  • One product, marketed as Ginkgo biloba, did not contain that ingredient. Instead it contained an unknown substitute; as such the safety of the product is unknown.
  • The second product was marketed as a supplement that included Ginkgo biloba. It also contained an unknown substitute, instead of Ginkgo biloba.
  • The third product, marketed as a fish oil supplement, contained the stated ingredients.

Supplement products, you will recall, are essentially unregulated, by Congressional fiat (see the Dietary Supplement Health and Education Act of 1994).

Since none of these supplements has been shown to improve memory, what’s in them only matters if it causes safety problems.  Fortunately, the study found contaminants to be a low levels.

When it comes to dietary supplements, caveat emptor.

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Nov 29 2018

NutraIngredients-USA on “Personalized Nutrition”

The food industry is intensely interested in personalized nutrition because it can create and sell products appeared to be aimed directly at individual lifestyles and preferences.

This approach is aimed much more at marketing than it is about public health.

With that said, take a look at how the food industry is using this idea.

Special Edition: Personalized Nutrition

The future is personal, but the revolution is already taking place around us. Innovative science is combining with entrepreneurial endeavor to bring personalized nutrition to our fingertips.

Personalized nutrition is breaking down the silos and bringing together experts in genetics and genomic profiling, microbiology, nutrition and diet, mobile technology, big data, healthcare and more.

In this special edition we talk to the pioneers and experts in this sector, the scientists and the emerging brands, and the tech developers bringing the personalized nutrition future to the present day.

Aug 6 2018

What’s in dietary supplements? NutraIngredients on transparency

NutraIngredients is another one of those industry newsletters I read every day.  Here is its collection of articles—a special edition—on supplements.  In the United States, supplement ingredients and labels are governed by the Dietary Supplement Health and Education Act of 1994, which effectively deregulated the products leaving the public to take the products on trust, sometimes justifiably, but sometimes not.

Special Edition: Transparency in Dietary Supplements

Issues concerning adulteration, identity and others swirl around the dietary supplement industry.  In this special edition, NutraIngredients-USA looks at the opportunities for proactively dealing with these questions in an effort to boost transparency and retain consumers’ trust.

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Mar 26 2018

Selling dietary supplements in Latin America

This comes from one of those daily food-industry newsletters I subscribe to, in this case NutraIngredients.com.  It occasionally focuses on regions and I thought this collection of articles was of interest.  Do Latin Americans need dietary supplements?  Just asking.

Welcome to NutraIngredients’ first quarterly supplement focusing on the Latin American dietary supplements and functional food markets. In this edition, we look at the changing regulatory landscapes across the region, including a deep dive into how Brazil is creating a distinct category for supplements. We’ll also look at a supplement start-up and opportunities for omega-3s in LATAM.

Dec 26 2017

Rattlesnake pills? Really? Contaminated with Salmonella?

I am indebted to food safety lawyer Bill Marler for enlightening me about these pills in the first place, and their contamination with Salmonella.

The Centers for Disease Control and Prevention and the Kansas Department of Health and Environment have linked one  person’s Salmonella Oranienburg infection to taking rattlesnake pills. Rattlesnake pills are often marketed as remedies for various conditions, such as cancer and HIV infection. These pills contain dehydrated rattlesnake meat ground into a powder and put into pill form. CDC recommends that you talk to your health care provider if you are considering taking rattlesnake pills, especially if you are in a group more likely to get a severe Salmonella infection.

Can’t wait to hear what your health care provider says about these.

 

Dec 19 2017

Never a dull moment: snortable chocolate?

I know that everyone loves chocolate, but to snort???

The FDA, ever on the job, has issued a warning letter to Arco Globus Trading that its snortable Coco Loko product–cocoa powder infused with caffeine, gingko, taurine, and guarana–is being marketed illegally as an unapproved street drug.

the claims made in your promotional materials for Legal Lean Syrup and Coco Loko demonstrate that these products are intended to be used as alternatives to illicit street drugs…With respect to Coco Loko, a powder substance, you describe it in your labeling as a “snuff” and you promote it to be “snorted” (inhaled intranasally).  Intranasal administration of a powder substance can trigger laryngospasm or bronchospasm and induce or exacerbate an episode of asthma.  Furthermore, the ingredients listed on the product label for Coco Loko include taurine and guarana.  The safety of these ingredients for intranasal administration has not been evaluated.

I can’t find an official website for the product (it seems to have disappeared) but the FDA says that Coco Loko does not qualify as a supplement (it is snorted, not eaten, and it actually intended for use as a street drug:

  • “Endorphin rush . . . it triggers a positive feeling of well being in your body similar to morphine.”
  • “Serotonin rush . . . will produce an elevated mood and a state of euphoria similar to the feeling of ecstasy.”
  • “Euphoric energy . . . Raw cacao will give you a steady rush of euphoric energy . . ..”
  • “Raw cacao . . . is also known to help with anxiety and to reduce stress.”
  • Coco Loko Review by I Suck At Talking (Youtube video on your website): “Raw cacao is linked to numerous health benefits . . . lower blood pressure and improved blood circulation . . ..” (1:04 – 1:13)

Snorting cocoa powder?  Really?  Not a good idea (even though no calories that way).

You can’t make this stuff up either.

Sep 18 2017

FDA wants comments on guidance for pre-DSHEA dietary ingredients

The FDA is taking comments about developing a list of dietary supplement ingredients in safe use before Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994.

It announced a public meeting for October 3 ton this issue.

The FDA also announced that it is accepting public comments on its draft guidance. on New Dietary Ingredients (NDIs).

Here are the FDA documents:

What this is about

A timeline may help:

  • 1994: Congress passed the Dietary Supplement Health and Education Act which essentially deregulated dietary supplements.
  • It did, however, require marketers of “New Dietary Ingredients (NDIs)” to submit a premarket notification to the FDA at least 75 days before introducing it—unless the ingredient had a history of safe use before that date.
  • 1997: FDA issues regulations for NDIs
  • 2011 (January): The Food Safety Modernization Act passes.  This required the FDA to clarify when an ingredient is considered NDI.
  • 2011 (July):  FDA publishes draft guidance
  • 2017 (September):  FDA issues draft guidance for comment

As the FDA explains, one purpose of this guidance is to improve compliance with the NDI notification requirement.

In 2012, FDA estimated that the number of dietary supplements on the market was 55,600 and that 5,560 new dietary supplement products come on the market each year. This is in contrast to the approximately 4,000 products that were on the market in 1994, when DSHEA was enacted.

As of December 2014, we had received and completed our evaluation of just over 750 NDI notifications since the first notification was received in 1995.

These figures, coupled with recent concern about the presence of undeclared active ingredients in products marketed as dietary supplements, highlight the importance of submitting NDI notifications as a preventive control to ensure that consumers are not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles

The FDA also explains:

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

How are we to interpret this?  

My take is that DSHEA is a public health disaster.  It allows supplement companies to use pretty much whatever ingredients they want and to continue doing so until there is substantial evidence for harm.

This must be an attempt by the FDA to exercise some kind of control over ingredients in supplements.  As such, the measure deserves support.

File comments by December 4; go to http://www.regulations.gov and type FDA-2017-N-4625 in the search box.

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